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MORPHINE SULFATE is a brand name for Morphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Morphine is used for the symptomatic relief of severe pain; relief of dyspnoea of left ventricular failure and pulmonary oedema; pre-operative use. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Morphine is used for the symptomatic relief of severe pain; relief of dyspnoea of left ventricular failure and pulmonary…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The dosage should be based on the severity of the pain and the response and tolerance of the patient. The usual adult subcutaneous or intramuscular dose is 10 mg every 4 hours if necessary, but may range from 5 mg to 20 mg.
5 mg to 15 mg not more than 4 hourly, where necessary, but dosage and dosing interval must be titrated against the patient’s response and adjustments made until analgesia is achieved. Elderly Because of the depressant effect on respiration, caution is necessary when giving morphine to the elderly.
A reduction of dose is advisable. Paediatric Population Not recommended for children under 1 year old. 5 – 5mg. The dose may be repeated every 4 hours if necessary. By intravenous injection over at least 5 minutes: 100 – 200micrograms/kg repeated every 4 hours if necessary.
(see table 1) By intravenous injection and infusion: initially by intravenous injection (over at least 5 minutes) 100-200 micrograms/kg (see table 1) then by continuous intravenous infusion 20 micrograms/kg/hour adjusted according to response.
• For chronic pain By intramuscular or subcutaneous injection: initially 150 – 200 micrograms/kg every 4 hours, adjusted according to response. (see table 2) ii) Children 6 - 12 years • For acute/post-operative pain By intramuscular or subcutaneous injection: 5 – 10mg, repeated every 4 hours if necessary.
By intravenous injection over at least 5 minutes: 100 – 200 micrograms/kg repeated every 4 hours if necessary. (see table 1) By intravenous injection and infusion: initially by intravenous injection (over at least 5 minutes) 100-200 micrograms /kg (see table 1) then by continuous intravenous infusion 20 micrograms/kg/hour adjusted according to response.
• Chronic pain By intramuscular or subcutaneous injection: initially 200 micrograms/kg every 4 hours, adjusted according to response. (see table 2) iii) Children 13 - 17 years • For acute/post-operative pain By intramuscular or subcutaneous injection: 10mg, repeated every 4 hours if necessary.
5–10 mg then by continuous intravenous infusion 20 micrograms/kg/hour adjusted according to response. • Chronic pain By intramuscular or subcutaneous injection: initially 5 – 20mg every 4 hours, adjusted according to response.
Hepatic Impairment:
9). The commonest side-effects of morphine are • Nausea • Vomiting • Constipation • Drowsiness • Dizziness Tolerance generally develops with long term use, but not to constipation.
Other side effects include the following:
Psychiatric disorders • Dependence. Immune system disorders: • Anaphylactic reactions following intravenous injection have been reported rarely, anaphylactoid reactions. Cardiac disorders: • Bradycardia • Palpitations • Tachycardia • Orthostatic hypotension.
4) • Hyperhidrosis Gastrointestinal disorders: • Dry mouth • Biliary spasm • Pancreatitis Eye disorders: • Blurred or double vision or other changes in vision • Miosis Reproductive system and breast disorders: • Long term use may lead to a reversible decrease in libido or potency.
• Central sleep apnoea syndrome Skin and subcutaneous tissue disorders: • Pruritus • Urticaria • Rash • Sweating. • Contact dermatitis has been reported and pain and irritation may occur on injection. • Facial flushing • Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders • Muscle rigidity Hepatobiliary disorders • Spasm of sphincter of Oddi Renal and urinary disorders: • Difficulty with micturition • Ureteric spasm • Urinary retention • Antidiuretic effect.
General disorders and administration site conditions : • Drug withdrawal (abstinence) syndrome Tolerance develops to the effects of opioids on the bladder. 4). Description of selected adverse reactions Drug dependence and withdrawal (abstinence) syndrome Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance.
An abstinence syndrome may be precipitated when opioid administration is suddenly discontinued, or opioid antagonists administered or can sometimes be experienced between doses. 4. Repeated use of Morphine Sulfate Solution for Injection can lead to drug dependence, even at therapeutic doses.
Repeated use can cause tolerance and dependence. Caution in use should be exercised and a reduction in dose may be advisable in the elderly and in the following cases: • Hypotension • Hypothyroidism • Depressed respiratory reserve • Prostatic hypertrophy • Hepatic or renal impairment (avoid or reduce dose) • Convulsive disorders • Asthma (avoid during attack) • Adrenocortical insufficiency • Urethral stricture • Inflammatory or obstructive bowel disorders Opioids such as morphine should either be avoided in patients with biliary disorders or they should be given with an antispasmodic.
Hepatobiliary disorders Morphine may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. 3). In patients given morphine after cholecystectomy, biliary pain has been induced.
Palliative care - in the control of pain in terminal illness, these conditions should not necessarily be a deterrent to use. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Morphine Sulfate Solution for Injection and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Morphine Sulfate Solution for Injection concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Acute chest syndrome (ACS) in patients with sickle cell disease (SCD) Due to a possible association between ACS and morphine use in SCD patients treated with morphine during a vaso-occlusive crisis, close monitoring for ACS symptoms is warranted.
4) • Head injuries, comatose patients or increased intracranial pressure. The sedation and pupillary changes produced may interfere with accurate monitoring of the patient. • Heart failure secondary to lung disease • Monoamine oxidase inhibitors (including moclobemide), or within two weeks of their withdrawal • Risk of paralytic ileus • Phaeochromocytoma (due to the risk of pressor response to histamine release).
• Acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis or diarrhoea caused by poisoning (until the toxic material has been eliminated)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Morphine may precipitate coma in hepatic impairment – avoid or reduce dose. Renal Impairment A reduced maintenance dose may be necessary in moderate to severe impairment. 73m2. Because the dose given to a child under 12 years is often based on their weight the following tables are provided to enable the calculated dose to be checked.
These tables used age related data based on mean values of weight. 78 ml Table 2: Dose (micrograms/Kg ) Age (Approx. 36 ml Doses and volumes for children must be calculated, measured and checked carefully by competent healthcare professionals to avoid error.
Particular care must be taken when measuring very small volumes. After calculation the information in these tables should be used to check that the dose and volume are appropriate for the specific age and weight of the child. Method of administration By intramuscular, subcutaneous or intravenous injection.
The subcutaneous route is not suitable for oedematous patients. The epidural or intrathecal routes must not be used as the product contains a preservative. Treatment goals and discontinuation Before initiating treatment with Morphine Sulfate Solution for Injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with Morphine Sulfate Solution for Injection it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of treatment Morphine Sulfate Solution for Injection should not be used longer than necessary.
4) Physiological withdrawal symptoms include: Body aches, tremors, restless legs syndrome, diarrhoea, abdominal colic, nausea, flu-like symptoms, tachycardia and mydriasis. Psychological symptoms include dysphoric mood, anxiety and irritability.
In drug dependence, “drug craving” is often involved. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Adrenal insufficiency Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. g. nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure.
Decreased Sex Hormones and Increased prolactin Long-term use of opioid analgesics may be associated with decreased sex hormone levels and increased prolactin. Symptoms include decreased libido, impotence or amenorrhea Hyperalgesia that does not respond to a further dose increase of morphine may occur in particular in high doses.
A morphine dose reduction or change in opioid may be required. Morphine has an abuse potential similar to other strong agonist opioids and should be used with particular caution in patients with a history of alcohol or drug abuse. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as Morphine Sulfate Solution for Injection.
Repeated use of Morphine Sulfate Solution for Injection can lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. Abuse or intentional misuse of Morphine Sulfate Solution for Injection may result in overdose and/or death.
The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (eg.
major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician. g.
too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored, and doses of morphine adjusted during and after treatment with rifampicin Morphine Sulfate Solution for Injection contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
5). Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
Severe cutaneous adverse reactions (SCARs) Acute generalized exanthematous pustulosis (AGEP), which can be life- threatening or fatal, has been reported in association with morphine treatment. Most of these reactions occurred within the first 10 days of treatment.
Patients should be informed about the signs and symptoms of AGEP and advised to seek medical care if they experience such symptoms. If signs and symptoms suggestive of these skin reactions appear, morphine should be withdrawn and an alternative treatment […]